Hypoglycaemia and Cardiac Arrhythmias in Type 2 Diabetes

CompletedOBSERVATIONAL
Enrollment

42

Participants

Timeline

Start Date

February 1, 2017

Primary Completion Date

January 6, 2020

Study Completion Date

January 6, 2020

Conditions
Diabetes Mellitus, Type 2Arrhythmia, Cardiac
Interventions
OTHER

Combined hyper- and hypoglycaemic clamp

During the entire clamp, participants will be monitored by ECG, pulse oximetry, and blood pressure and plasma glucose will be measured bedside every fifth minute. Additionally, patients with type 2 diabetes will be monitored by a loop recorder (LR) and a continuous glucose monitor (CGM). Comparison of LR and CGM recordings with the recordings obtained by ECG Holter monitor and blood sampling will be used for validation of the method used in Part 2 of the study. Blood samples will be drawn and analysed for changes in electrolytes, insulin, glucagon, catecholamines and cortisone. A cardiac haemodynamic evaluation will be performed by echocardiography at baseline, hyperglycaemia, and hypoglycaemia.

DEVICE

Loop recorder (Reveal LINQ, Medtronic, Minneapolis, MN, USA)

Implantation of a loop-recorder

DEVICE

Continuous glucose monitoring (iPro2, Medtronic, Minneapolis, MN, USA)

Monitoring with a continuous glucose monitor

Trial Locations (1)

2900

Gentofte Hospital, Hellerup

All Listed Sponsors
lead

University Hospital, Gentofte, Copenhagen

OTHER

NCT03150030 - Hypoglycaemia and Cardiac Arrhythmias in Type 2 Diabetes | Biotech Hunter | Biotech Hunter